Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/65877
Type: Artigo de periódico
Title: Evaluation of pantoprazole formulations in different dissolution apparatus using biorelevant medium
Author: de Campos, DR
Klein, S
Zoller, T
Vieria, NR
Barros, FAP
Meurer, EC
Coelho, EC
Marchioretto, MA
Pedrazzoli, J
Abstract: Purpose. The study was developed to compare the in vitro dissolution profiles of pantoprazole (CAS 102625-70-7) formulations in both The United States Pharmacopeia (USP) apparatus 2 and 3 by applying biorelevant medium. Moreover, an in vitro-in vivo relationship was proposed considering in vivo data from a previously published study. Methods: In vitro dissolution profiles were evaluated in biorelevant medium in USP apparatus 2 and 3 and the dissolution curves were either compared by the similarity factor (f(2)) or a model-independent approach. The fraction of drug dissolved in vitro in apparatus 2 was compared with the fraction of drug absorbed in vivo, which was obtained from a retrospective in vivo study. An in vitro-in vivo relationship analysis was then applied to elucidate the overall absorption characteristics of formulations. Results: The dissolution profiles of formulations demonstrated similar disposition in biorelevant medium in both USP apparatus 2 and 3. The dissolution profiles were described by f(2) model in apparatus 2 and Weibull's function in apparatus 3. The vitro-in vivo relationship analysis showed that the formulations exhibited permeability rate-limiting absorption. Conclusion: Biorelevant medium in both USP apparatus 2 and 3 may be used as a tool to predict in vivo disposition of formulations of pantoprazole. Furthermore, it can be argued that biowaiver can be granted for enteric coated formulations of pantoprazole on the basis of in vitro dissolution profile.
Subject: Biopharmaceutics classification system
Biorelevant dissolution testing
CAS 102625-70-7
In vitro-in vivo correlation
Pantoprazole
Country: Alemanha
Editor: Ecv-editio Cantor Verlag Medizin Naturwissenschaften
Rights: aberto
Date Issue: 2010
Appears in Collections:Unicamp - Artigos e Outros Documentos

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